Anlotinib in Advanced Solid Tumors With FGFR Alteration


This clinical trial aims to evaluate the efficacy, safety of Anlotinib in advanced solid tumors with FGFR alteration.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2020


  • Drug: Anlotinib
    • Anlotinib

Arms, Groups and Cohorts

  • Experimental: advanced solid tumors with FGFR alteration

Clinical Trial Outcome Measures

Primary Measures

  • Objective Response Rate(ORR)
    • Time Frame: up to 36 months
    • Evaluation of tumor burden based on RECIST criteria.

Participating in This Clinical Trial

Inclusion Criteria

Patients should be histologically diagnosed with advanced solid tumors; Patients with FGFR mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Changzheng Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhan Wang, Anlotinib in advanced solid tumors with FGFR alteration – Shanghai Changzheng Hospital

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